This notice describes policies and procedures for investigators who wish to request an extension of the NIH-defined Early Stage Investigator (ESI) classification period. NIH ESI policies were developed to encourage early transition to independence. As previously described, ESIs are New Investigators who are within ten years of completing their terminal research degree or within ten years of completing their medical residency. In some cases, there may have been one or more lapse in the period of research or research training after the terminal degree or the completion of medical residency. This notice describes the procedures for requesting an extension of the ESI period and the conditions under which such extensions will be considered.

Background

The involvement of New Investigators is considered essential to the vitality of the health-related research enterprise and has been addressed by several important NIH programs and studies which are detailed on the New and Early Stage Investigator Website at http://grants.nih.gov/grants/new_investigators/index.htm. The website includes a comprehensive description of the NIH ESI policies, relevant announcements, and definitions. As previously stated (see NOT-OD-09-013), the NIH will consider an R01 applicant’s status as a New Investigator and/or an ESI at the time of peer review and award.

Identifying ESIs

All New Investigators have been instructed to update their eRA Commons profiles to ensure that they are given appropriate consideration on R01 applications beginning with the February 2009 grant due dates (see notice at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-021.html and information on standard due dates at http://grants1.nih.gov/grants/funding/submissionschedule.htm). The eRA Commons will identify New Investigators by searching the eRA database for individuals with evidence of applicable previous support. Those individuals, who have not competed successfully for significant NIH research grant support, as described at http://grants1.nih.gov/grants/new_investigators/index.htm, will be considered New Investigators. Those New Investigators who are within the 10 year period that begins at the completion of the terminal research degree or the completion of medical residency additionally will be considered ESIs.

The eRA Commons is being updated. Currently, investigators can enter the date of their terminal research degree. The functionality required to indicate the residency field and end date of residency will become available on January 17, 2009. Also, on that date, the data system will begin calculating and displaying the ESI status. The entered date of terminal degree and/or the entered date of completion of medical residency will be used to determine the ESI status and the end of eligibility date. Degree and residency dates will be entered as month and year. The ESI status end date will be calculated and reported as month and year. Individuals who are identified as New Investigators and/or ESIs by the functionality built into eRA Commons will receive email notification of their status beginning on January 17, 2009.

For most Commons account holders, the terminal research degree will be a doctoral degree such as a Ph.D., M.D., or an M.D./Ph.D. Research degrees received after the initial doctorate should be entered only when the degree establishes the beginning of a period of research or research training or the new degree substantially expands or advances an individual’s skills within a field related to the NIH mission. Degrees received after the initial doctorate in fields unrelated to the NIH research mission should not be listed. For example, normally it would not be appropriate to enter a non-research degree such as an M.B.A., M.F.A. or J.D. Commons account holders who do not have a research doctorate should list their most advanced degree. For example, in the absence of a doctorate, degrees such as a B.S., M.S., or an M.P.H. could be entered as the terminal research degree and will initiate the ESI period. For eRA Commons account holders with clinical training, the period of medical residency refers to the period of post-graduate, medical training that includes the internship and residency. The medical residency does not include clinical fellowships associated with training in a medical specialty or subspecialty. Extended periods of clinical training within a recognized area of specialization after the residency may constitute a reason to request an extension of the ESI period, as described below.

General Principles for Extending the Period of ESI Status

In general, ESI status will be applied to New Investigators who have had less than 10 years of research or research training experience after the completion of their terminal research degree or medical residency. Some new investigators will experience a lapse in their research or research training or they will experience periods of less than full-time effort during the 10 year ESI period. In order to accommodate such lapses, the NIH will consider requests to extend the ESI period for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service. In general, the NIH will extend the period of ESI status for a period equivalent to the time away from research or research training. Extensions related to periods of part-time status normally will be prorated to reflect the actual time away from research and normally will be considered only when the appointment is reduced by 50% or more for a sustained period of time.

Process for Requesting an Extension

New Investigators who wish to request an extension of ESI eligibility will be able to find a web-form on January 17, 2009. A link to the WebForm will be provided on the New and Early Stage Investigator Webpage at http://grants.nih.gov/grants/new_investigators/index.htm. Once a request for extension has been completed and transmitted to the NIH, it will be considered by the NIH ESI Extensions Committee composed of senior-level NIH staff. It is possible that this committee will request additional material to document the hiatus in research effort. Once all material is received, the request generally will be processed within two weeks. After a determination is made by the NIH ESI Extensions Committee, the requestor will be notified of the decision by email. If the ESI status period is extended, the revised end date of the ESI period will be displayed in the requestor’s eRA Commons profile.

Evaluating a Request for Extension – Factors to be Considered

Family Care Responsibilities: Investigators, both male and female, may request an extension of ESI status equivalent to the amount of time away from research because of family care responsibilities that have occurred during the ten year period after the terminal research degree or the end of medical residency. Family care responsibilities can include the birth or adoption of a child, or the direct care of sick, injured, or disabled children or other close family members.

Extended Periods of Clinical Training: Clinicians often engage in a period of extended post-residency training associated with preparation for practice in specialty or subspecialty fields. The NIH will consider ESI extensions for those segments of post-residency clinical training that are exclusively devoted to training in clinical care. Those parts of post-residency training that involve research in clinical or laboratory settings should not be included in the period of time requested to extend ESI status. Those requesting extensions of the ESI period should carefully describe the duration of those sections of their fellowship training that involved clinical training.

Extended Periods of Additional (non-degree) Research Training: Research training in a formal (non-degree) NIH-relevant, training program that involves periods of didactic instruction and limits the time available for research or research training may be considered. Those requesting extensions on this basis should describe (and prepare to document) the period of training including course work and other non-research activities. Formal research training programs during the post doctoral period that result in a master’s or other degree in a field that substantially expands or advances an individual’s skills related to the NIH mission, should be entered as a new terminal research degree, as stated above.

Disability or Illness: New Investigators who have had a hiatus in their career because of illness or disability within the first ten years after completing their research degree or their medical residency may request an extension of the ESI period equivalent to the time away from research.

Active Duty Military Service: New Investigators who have interrupted their research or research training for active duty military service within the first ten years after completing their research degree or their medical residency may request an extension of the period of ESI status equivalent to the period of active service. This is not restricted to service in the United States military.

Clinical Loan Repayment Requirements: Some federal loan repayment programs require a period of clinical practice following completion of clinical training. New investigators who have interrupted their research or research training within the first ten years after completing their research degree or their medical residency to satisfy a service obligation associated with a federal loan may request an extension of the period of ESI status equivalent to the period of obligation.

Natural or Other Disaster: Early Stage Investigators who have had major interruptions in research due to a catastrophic event (hurricane, flood, fire, etc.) that led to a laboratory shut down or relocation may request an extension of the period of ESI status equivalent to the time of closure or relocation/set-up.

The information described in the request for an ESI extension will be considered confidential, and will be maintained under the Privacy Act record system 09-25-0036, “Extramural Awards” which can be found at http://oma.od.nih.gov/ms/privacy/pa-files/0036.htm. The individual submitting a request for ESI extension will be responsible for providing true, accurate, and complete information.